Elicitation of societal preferences for chronic lymphocytic leukemia's treatments: a discrete choice experiment.

The overall value of treatments for chronic lymphocytic leukemia (CLL) depends on several factors, including preferences of the general population, who contributes to the financing of health systems. This study investigated societal preferences for attributes of CLL treatments in Italy. An online large-scale survey was designed using a discrete choice experiment (DCE) methodology and delivered to the Italian adult general population. Ten treatment attributes were identified, covering efficacy, safety, operational aspects and (hypothetical) out-of-pocket cost. DCE data were analyzed using a mixed logit regression model, estimating the willingness-to-pay for attribute levels' change. The general population significantly preferred more effective treatments, with shorter duration, administered orally rather than orally + intravenously. Changes in therapy duration, frequency of checkups and organ damage risk had the greatest impact on preferences. The integration of societal preferences in the value judgments of CLL therapies may help health authorities in establishing priority setting and taking pricing-reimbursement decisions.

Economic impact of a more extensive use of FENO testing on the Italian population with asthma.

BACKGROUND: Asthma is a common chronic inflammatory airway affecting over 260 million people worldwide, and characterized, in the large majority of cases, by the so-called "type 2 inflammation". Fractional exhaled nitric oxide (FENO) testing is noninvasive point-of-care tool to assess type 2 inflammation and therefore improve asthma management. It has been suggested to determine eligibility for a specific biologic therapy and predict likelihood to respond. The aim of this study was to estimate the overall economic impact of an extensive use of FENO testing on the Italian population with asthma, including extra costs of testing and savings generated by more appropriate prescriptions, increased adherence and lower frequency of exacerbations. METHODS: A cost of illness analysis was firstly performed to estimate the yearly economic burden from the National Healthcare Service (NHS) perspective in Italy of the management of asthmatic patients with standard of care (SOC) according to the application of GINA (Global Initiative for Asthma) guidelines; then, we evaluated the changes in the economic burden in patient management by introducing FENO testing into clinical practice. The cost items considered were: visits/exams, exacerbations, drugs, management of adverse events caused by short-term oral corticosteroids use. Efficacy of FeNO test and SOC is based on literature evidence. Costs refer to published data or Diagnosis Related Group/outpatient tariffs. RESULTS: Considering one asthma visit every 6 months, the total yearly cost for the management of patients with asthma in Italy is 1,599,217,876€ (409.07€ per patient), while for FENO testing strategy this figure is 1,395,029,747€ (356.84€ per patient). An increased utilization rate of FENO testing from 50 to 100% of patients may lead to savings for the NHS from about 102 to 204 million € compared to SOC. CONCLUSIONS: Our study showed that FeNO testing strategy may improve the management of asthmatic patients leading to significant savings for the NHS.

Frequency and clinical meaning of long-term degenerative changes after lumbar discectomy visualized on imaging tests.

The aim of this retrospective controlled study was to evaluate radiographic degeneration in the lumbar spine of patients who had undergone lumbar discectomy minimum 21 years earlier and its clinical meaning. Indeed, no previous investigation on degenerative changes occurring after lumbar discectomy with a comparable long follow-up has been published. The study participants consisted of 50 patients who had undergone discectomy for lumbar disc herniation. The mean length of follow-up was 25.3 +/- 3.0 years. Patients were assessed by Short Form-36 Health Survey (SF-36), Oswestry Disability Index, and a study-specific questionnaire. Radiographic views of the lumbar spine were obtained from all patients and compared to those of 50 asymptomatic controls. A five-step published classification was used to assess the increasing severity of radiographic changes. CT or MRI scans were also available for 27 patients who had undergone discectomy. Moderate to severe radiographic changes were present in 45 patients (90%) and 34 controls (68%), respectively (P = 0.013). The most prevalent MRI/CT changes were loss of disc height (89%), facet joint arthritis (89%), and endplate changes (57%). Thirty-two of 33 subjects (97%) reporting pain during the last 12 months had significant degeneration on their radiographs, and the frequency of changes was higher with respect to subjects without pain (P = 0.040). In conclusion, standard lumbar discectomy frequently leads to long-term degenerative changes on imaging tests. The presence of moderate to severe degeneration is associated with self-reported pain.

An enlarging distal tibia osteochondroma in the adult patient.

The extensive enlargement of a solitary osteochondroma in a skeletally mature patient is rare and might result from malignant transformation. Excision of such a lesion in the distal and lateral aspect of the tibia is difficult because of the risk of injury to the neurovascular structures and the possible functional consequences with respect to ankle stability. We present a case of an active osteochondroma arising from the posterolateral distal tibia in an adult patient. The tumor was successfully excised by using a transfibular approach with fibular reconstruction. No signs of recurrence were noted 2 years after surgery.

Platelet gel supplementation in long bone nonunions treated by external fixation.

OBJECTIVE: The aim of the present study was to evaluate the use of previously frozen, thawed platelet gel supplementation to accelerate the healing of long bone nonunions treated by external fixation. DESIGN: Prospective case series with historical controls. SETTING: University Hospital. PATIENTS: Twenty patients affected by tibial, humeral, or forearm atrophic nonunions were treated by percutaneous stabilization with unilateral external fixators and injection of autologous platelet gel. The healing time was compared to the result obtained in a historical control group treated without platelet gel supplementation. MAIN OUTCOME MEASUREMENTS: Consolidation rate and radiographic healing time of nonunions in the 2 groups were assessed by independent blinded observers. The nonunion was judged to be healed when bridging callus formation on both radiographic views was observed on at least 3 of 4 cortices. RESULTS: The healing rate of nonunion was 90% (18/20) in platelet gel cases and 85% (17/20) in controls, respectively (P = 0.633). The mean time until radiographic consolidation in nonunions supplemented with platelet gel (147 +/- 63 days) was not different to the result in the control group (153 +/- 61 days; P = 0.784). Analyzing the mean healing time for separate segments, no differences were noted between study and control group-that is, tibia: 112 +/- 43 and 130 +/- 5 days, respectively (P = 0.382); humerus, 225 +/- 36 and 202 +/- 70 days, respectively (P = 0.530). CONCLUSION: The present study failed to show the clinical usefulness of isolated percutaneous platelet gel supplementation in long bone nonunions treated by external fixation; however, caution should be exercised in interpreting this result because the actual numbers are small and the statistical power is limited.

Expandable intramedullary nailing and platelet rich plasma to treat long bone non-unions.

BACKGROUND: Roentgenographic and functional outcomes of expandable self locking intramedullary nailing and platelet rich plasma (PRP) gel in the treatment of long bone non-unions are reported. MATERIALS AND METHODS: Twenty-two patients suffering from atrophic diaphyseal long bone non-unions were enrolled in the study. Patients were treated with removal of pre-existing hardware, decortication of non-union fragments, and fixation of pseudoarthrosis with expandable intramedullary nailing (Fixion, Disc'O Tech, Tel Aviv, Israel). At surgery, PRP was placed in the pseudoarthrosis rim. RESULTS: The thirteen-month follow-up showed 91% (20/22 patients) of patients attaining bony union. The average time to union was 21.5 weeks. No infection, neurovascular complication, rotational malalignment, or limb shortening >4 mm were observed. The healing rate of non-unions was comparable to that observed in previous studies but with a lower complication frequency. CONCLUSIONS: The combined use of self locking intramedullary nailing and PRP in the management of atrophic diaphyseal long bone non-unions seems to produce comparable results with less complications than previously reported. Further data are warranted to investigate the single contribution of PRP gel and Fixion nail.

Relationship between alterations of the lumbar spine, visualized with magnetic resonance imaging, and occupational variables.

Although the effect of physical workload on the occurrence of low back pain (LBP) has been extensively investigated, few quantitative studies have examined the morphological changes visualized via magnetic resonance imaging (MRI) in relation to occupational variables. The relationship between the severity of some abnormalities such as lumbar spinal stenosis or spondylolisthesis and physical or psychosocial occupational risk factors has not been investigated previously. In this cross-sectional study patients fulfilled the following inclusion criteria: (1) long-standing (minimum 1-year) LBP radiating down the leg (or not); (2) age more than 40 years; (3) willingness to undergo an MRI of the lumbar spine; and (4) ability to speak Italian. Primary objective of the study was to investigate the association between occupational exposure and morphological MRI findings, while controlling for the individual risk factors for LBP. Secondarily, we looked at the influence of this exposure and the degenerative changes in the lumbar spine on clinical symptoms and the related disability. Lumbar MRI scans from 120 symptomatic patients were supplemented by the results of structured interviews, which provided personal, medical, and occupational histories. All occupational factors were arranged on scales of increasing exposure, whereas pain and disability were assessed using ad hoc validated questionnaires. Evidence of intervertebral disc narrowing or herniation and the occurrence and severity of spinal stenosis and spondylolisthesis was obtained from the MRI scans and a summative degenerative score was then calculated. We detected a direct association between increasing age and the global amount of degenerative change, the severity of intervertebral disc height loss, the number of narrowed discs, stenosis, the number of stenotic levels, and spondylolisthesis. Physical occupational exposure was not associated with the presence of lumbar disc degeneration and narrowing per se, but a higher degree of such an exposure was directly associated with a higher degree of degeneration (P=0.017). Spondylolistesis and stenosis were positively related to heavy workload (P=0.014) and the manual handling of materials (P=0.023), respectively. Psychosocial occupational discomfort was directly associated to stenosis (P=0.041) and number of stenotic levels (P=0.019). A heavier job workload was the only occupational factor positively related to the degree of disability at the multivariate analysis (P=0.002). Total amount of degeneration in the lumbar spine directly influenced pain duration (P=0.011) and degree of disability (P=0.050). These results suggest that caution should be exercised when symptomatic subjects with evidence of degenerative changes on MRI scans engage in strenuous physical labor.

Osteoarticular tuberculosis in a developed country.

OBJECTIVES: To evaluate the clinical and diagnostic features of osteoarticular tuberculosis (OT) from a series of cases seen over 30 years in a large university hospital in Naples, Italy. METHODS: We reviewed the files of all patients admitted to our department from 1975 to 2004 with a diagnosis of osteoarticular tuberculosis. RESULTS: We identified 136 patients with 140 osteoarticular tuberculosis lesions. Fifty-three cases were diagnosed from 1975 to 1984, 36 cases from 1985 to 1994, and 47 cases from 1995 to 2004. Eleven patients (8%) were from high-incidence areas outside of Italy. The mean delay until diagnosis was 216.6 days. Pain, low-grade fever, and loss of weight were the most common presenting symptoms. Neurological involvement was present in 11 cases out of 79 spinal lesions (13.9%). Serological methods were used to study antimycobacterial antibodies using enzyme-linked immunosorbent assays (ELISA-TB test) in 59 patients (42.1%). Positive results on this test were obtained in 43 patients (72.9%). ELISA-TB test was the only diagnostic test associated with a shorter diagnostic delay in a model of multivariate regression analysis (p=0.001). Tc-99m MDP bone scans were obtained from 83 patients with 84 lesions and increased uptake in the affected area was noted in 72 lesions (85.7%). Histological and microbiological examinations were positive in 97 (69.3%) and 57 (40.7%) lesions, respectively. In 43 (30.7%) lesions, we could not definitively confirm the diagnosis. In these cases chemotherapy was nevertheless initiated. CONCLUSIONS: Thorough and even invasive diagnostic work-up is mandatory for the proper and timely management of patients with OT. Tc-99m MDP bone scanning and ELISA-TB test are useful diagnostic tools. We always used microbiological testing and histological examination to confirm the diagnosis of OT, but empirical antituberculosis treatment was nevertheless initiated in the patients with high clinical suspicion in order to limit the potentially permanent destruction of affected skeletal segments.

Minimum 25-year outcome and functional assessment of lumbar discectomy.

STUDY DESIGN: A retrospective, follow-up cohort study. OBJECTIVE: To evaluate the 25-year (or longer) outcome of discectomy for lumbar disc herniation by validated instruments. SUMMARY OF BACKGROUND DATA: A comprehensive patient-oriented evaluation should include measurements of pain and disability along with a reliable evaluation of the general health status. There is a paucity of data from validated measuring instruments on the very long-term outcome of lumbar discectomy. METHODS: We conducted a follow-up study of 201 patients an average of 27.8 years (range 25-32) after lumbar discectomy. The patient-oriented assessment included a Short Form-36 Health Survey questionnaire, Oswestry Disability Index, Cumulative Illness Rating Scale, and a study specific questionnaire dealing with daily life activities and satisfaction with the surgery. RESULTS: The Short Form-36 Health Survey physical scales and summary scores were similar to the normative values for healthy subjects and were better than the scores of patients with untreated sciatica with respect to reported pain. The mean Oswestry disability score was 17.5. Satisfaction with surgery was expressed by 181 of 201 patients (90%). CONCLUSIONS: Patients who had undergone lumbar discectomy a minimum of 25 years earlier have a satisfactory self-reported health-related quality of life and less pain than nonsurgically treated subjects.

Unilateral laminectomy for bilateral decompression of lumbar spinal stenosis: a prospective comparative study with conservatively treated patients.

The authors performed single- or multiple-level unilateral laminectomy to treat lumbar spinal stenosis in patients with mild to moderate leg pain and compared the results with those from patients treated with conservative therapy in a prospective study. This decompression technique produced a 68% rate of improvement compared with a 33% rate for conservatively treated patients. The surgical group exhibited significant and sustained improvement, whereas the functional and clinical status of the conservatively managed group had returned to baseline during the same period. The preoperative dural sac cross-sectional area at the level of the most stenosis was 70.76 +/- 28.2 mm(2) for the surgical group, whereas on postoperative scans it was 108.12 +/- 31.5 mm(2), with an average correction rate of 65%. Neither new degenerative spondylolisthesis nor any evidence of instability was detected in any patient during the study.